This is a pilot study evaluating the feasibility of intravenous calcium and magnesium (Ca/Mg) infusion for prevention of taxane induced neuropathy in patients with early stage breast cancer receiving adjuvant or neo-adjuvant paclitaxel, either given every 2 weeks for 4 cycles or every week for 12 weeks.

The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls

Secondary Outcome Measures:

Other measures of neuropathy and quality of life [ Time Frame: 2 years ] [ Designated as safety issue: No ]

The secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-TAX score

Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel

Other Names:

Ca

Mg

Calcium

Magnesium

Detailed Description:

Chemotherapy induced peripheral neuropathy (CIPN) is a major dose limiting side effect of many cytotoxic chemotherapy, and can be extremely disabling, causing significant loss of functional abilities. Calcium and magnesium infusions were shown to decreased the incidence and intensity of neuropathy symptoms related to oxaliplatin.

There are currently no effective drugs or treatment modalities for the prevention or treatment of taxane related neuropathy. Given the morbidity of taxane induced neuropathy and the safety of Ca/Mg infusion, it is reasonable to assess the feasibility of this intervention in woman with stage I-III breast cancer receiving adjuvant or neo-adjuvant paclitaxel treatment, either given every 2 weeks for 4 cycles or every week for 12 weeks. Calcium gluconate and magnesium sulfate, 1 g of each agent in 100 ml D5W will be infused over 30 minutes, immediately before and after each dose of paclitaxel. The Ca/Mg infusion will be given through the same line used for giving chemotherapy.

The primary aim of this study is to assess paclitaxel-related neuropathy (grade 2 or greater) as measured by NCI Common Terminology Criteria Version 3 in patients receiving Ca/Mg infusion during paclitaxel chemotherapy and compare it with historical controls. Secondary endpoints will include other measures of neuropathy and quality of life such as the FACT-Tax score, taxane-related neuropathy pain as measured by the Brief Pain Inventory-Short Form (BPI-SF), and measure of cognitive impairment using FACT-cog score.

Eligibility

Ages Eligible for Study:

21 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Age > 21 years

History of stage I-III breast cancer

Patient scheduled to be receiving adjuvant or neo-adjuvant paclitaxel given every week for 12 weeks or given every two weeks for 4 cycles

Serum magnesium level ≤ UNL

Serum calcium level ≤ UNL

Serum creatinine ≤ 1.5 x UNL

Signed informed consent

Exclusion Criteria:

Pre-existing peripheral neuropathy of any grade

Current treatment for arrhythmias

Concurrent treatment with anticonvulsants, tricyclic antidepressants, or other neuropathic medications such as carbamazepine, phenytoin, gabapentin, lamotrigine, or concurrent treatment with other neuropathic chemotherapy agents

Current narcotic use

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01682499